Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment

PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS

The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis.

The antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. Also will evaluate the safety of both products.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Bepotastine Besilate 1.5% PF; Drug: Olopatadine Hydrochloride 0.2% BAK

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, B1888
    • Hospital de Alta Complejidad El Cruce - Nestor Kirchner
  • Caba, Argentina, C1232AAC
    • Hospital Santa Lúcia
  • Caba, Argentina, C1416 DJI
    • Instituto Oftalmológico Pedro Lagleyze
  • Caba, Argentina, C1437
    • Hospital Churruca - Visca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients older than 18 years old.
• Clinical diagnosis of allergic conjunctivitis and active allergy with at least 2 points on itching and hyperemia scale.
• Patients with history of allergic conjunctivitis.
• Patients who accept no to wear contact lens during the duration of the trial.
• Patients who accept no to use any other medication by any delivery route.
• Patients with intraocular pressure controlled (less than 18 mmhg)

Exclusion Criteria:

• Patients who have undergone refractive surgery within the 6 months prior to the start of the study
• Patient with ocular or systemic active diseases
• Patients who are participating in another trial
• Patients who have used eye medication in the last 15 days and/or who have received anti-inflammatory drugs (corticosteroids and/or NSAIDs) and/or antihistamines by mouth or intravenous.
• Patients hypersensitive to any component of the products: Bepotastine besilate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide, Olopatadine hydrochloride, benzalkonium chloride, dibasic sodium phosphate, hydrochloric acid, edetate disodium or povidone K29 / 32.
• Women who are breastfeeding and pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bepotastine besilate 1,5% preservative free; Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning.	Drug: Bepotastine Besilate 1.5% PF; Bepotastine besilate 1,5% Preservative free ophthalmic solution; Other Names: TRALER LC
Active Comparator: Olopatadine hydrochloride 0,2% with BAK; Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning.	Drug: Olopatadine Hydrochloride 0.2% BAK; Olopatadine hydrochloride 0.2% with BAK as preservative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular itching	Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops.	Baseline, Day 15, Day 30, Day 45, Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye burning	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Eye lacrimation	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Foreign body sensation	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Rhinorrhea	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Nasal congestion	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Nasal pruritus	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Eyelid swelling	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Visual Acuity	Improve from baseline.	Baseline and Day 60
Meniscus height	Differences between treatments.	Baseline, Day 15, Day 30, Day 45, Day 60
Conjunctival hyperemia	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Chemosis	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Eye discharge	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)	Baseline, Day 15, Day 30, Day 45, Day 60
Conjuctival impression cytology	Differences between treatments. Nelson classification.	Baseline, Day 30, Day 60
Adverse reactions		Baseline, Day 15, Day 30, Day 45, Day 60.

Collaborators and Investigators

• Sponsor: Laboratorios Poen

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Bepotastine besilate; Olopatadine Hydrochloride
• Other Study ID Numbers: ANTILERG001-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No